MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Entrapment of Device (1212)

Patient Problems Physical Entrapment (2327); Blood Loss (2597)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).A transesophageal echocardiogram (tee) was performed to confirm entrapment.The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.Post procedure, the patient underwent a blood transfusion due to blood loss but is currently stable.

Manufacturer Narrative

Event summary: patient data files showed ten applications were performed with catheter 2af284/4062 the date of event.Patient file showed system notice (50003) was received indicating that the pressure was low in the system at application #1 and 2, most likely due to closed gas tank.The mapping catheter performance is not captured through patient data file.The case was aborted and the patient was under general anesthesia.It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.The mapping catheter was not returned for investigation.In conclusion, this is a case related to a clinical adverse event (entrapment).The reported issue could not be assessed through data analysis.There is no indication of relation of adverse event to the performance and malfunction of the product.The mapping catheter was not returned for investigation.The case was aborted while the patient was under general anesthesia.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7877814
• MDR Text Key: 120310689
• Report Number: 3002648230-2018-00656
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 67